本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3月6日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。

本期要闻: 中小型企业考虑在最惠国待遇下拓展欧洲市场；辉瑞CEO谈FDA疫苗审批决策；人工智能时代大型药企对CRDMOs有何期待；神经科学研究资金蓄势复苏；优时比与中国达成重大合作。

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-N3WEPHD34BHGBGRM5BNJPTS2NY/

Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX



Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar.9, 2026

What if a drug could kill cancer cells broadly, spare the immune system and then train it to keep fighting, without triggering resistance? That's the promise behind the ELANE pathway, a mechanism discovered not from a hypothesis but from studying fundamental biology in patients.
 
In this episode of the In Vivo Podcast, Court Turner, CEO and co-founder of Onchilles Pharma, and Lev Becker, CSO and scientific founder, discuss how a neutrophil elastase-based mechanism is being translated into N17350, a first-in-class intratumoral agent targeting solid tumours including head and neck, skin and breast cancers.
 
With $40m raised, GMP manufacturing of thousands of clinical doses completed, a US IND approved, and a first-in-human study underway in Australia, Onchilles is moving from "stubborn optimism" to clinical execution. Court and Lev discuss the dual mechanism that sets N17350 apart from both traditional chemotherapy and immunotherapy, why histone H1 functions as a universal tumour vulnerability rather than a conventional biomarker, and how they're thinking about combinations, partnering and the eventual value story for payers.

Killing Cancer Loudly: Onchilles Pharma's Neutrophil-Derived Path to Pan-Cancer Therapy

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs discuss potential directions for the US Food and Drug Administration’s Center for Biologics Evaluation and Research after the departure of Director Vinay Prasad (:32), including similarities between the center’s leadership issues and the staffing problems in the Harry Potter saga’s Hogwarts School of Witchcraft and Wizardry (7:48), as well as the potential policy implications (10:11). They also discuss the contributions of the agency’s Real-Time Oncology Review (RTOR) pilot program to the quick reviews of two Commissioner’s National Priority Voucher (CNPV) awardees (17:19).

More On These Topics From The Pink Sheet

US FDA’s Vinay Prasad, Controversial CBER Director, Leaving In April: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-vinay-prasad-controversial-cber-director-leaving-in-april-DJO7ACE73RCNTLZKQWCN2S26LM/ 

US FDA’s CNPV Approvals Ride RTOR Pilot’s Coattails: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fdas-cnpv-approvals-ride-rtor-pilots-coattails-3HEGU5MDWJEG7OYHSZQR6TE5NM/ 

Drug Fix: US FDA’s Prasad Leaves, Harry Potter, And Is CNPV Effective Because Of RTOR?

Audio roundup of selected biopharma industry content from Scrip over the business week ended Mar.13, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools.

This time – Roche faces giredestrant Phase III setback; founders exit BioNTech; Ipsen to withdraw Tazverik; tough times for Bayer; and another boost for UCB’s Bimzelx.  

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LMR3CRGKRFDWLHTOSBRDCRM7GE/

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - Mar.16, 2026

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3月13日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。

本期要闻: 罗氏的吉雷德斯特兰特（giredestrant）III期试验遭遇挫折；BioNTech创始人退出公司； 伊普森将撤回Tazverik；拜耳面临困境；以及UCB的Bimzelx再获利好。

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LMR3CRGKRFDWLHTOSBRDCRM7GE/

Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar.16, 2026

Probiotics remain one of the fastest‑growing segments in consumer health, but companies still face the challenge of operating in a fragmented claims environment, building credible brands, and communicating benefits to increasingly savvy consumers.
In part two of HBW Insight’s interview with probiotics expert, David Pineda Ereno, we explore how leading players are finding ways through this complexity: from launching strategically in more permissive markets like Italy and France, to using umbrella brands and authorised nutrient claims to support probiotic innovation.
Finally, we turn to postbiotics, a newer but fast‑developing area that could open up additional commercial opportunities. With their stability and easier formulation, postbiotics are gaining traction — but they bring their own regulatory considerations too
 
Guest Bio:
David Pineda Ereño is managing director of DPE International Consulting, an international consultancy firm that provides strategic and regulatory advice on the policy, regulation and trade of foods and food supplements. David has over 20 years of experience providing strategic solutions to companies, trade associations, and government bodies at national, regional, and international level, in Europe, Latin America, Asia, Middle East and Africa, and the US.

Winning In The Probiotics Space, With David Pineda Ereño

The final week of February saw the AAM hold its Access! 2026 annual conference in Miami and Medicines for Europe hold its annual regulatory and scientific affairs conference in Amsterdam. Generics Bulletin was there at both events and our reporters discuss the key takeaways in our latest podcast.

The Generics Bulletin Podcast: 2026 Conferences

최근 미국의 BIO 투자자 및 성장 서밋에서 투자자들은 초기 단계 신경과학 분야의 자금 조달 환경이 여전히 어렵지만, 이 분야에 대한 관심이 높아지고 있다는 징후가 보인다고 말했습니다. Scrip이 취재한 내용을 요약했습니다.

AI 기반 텍스트 음성 변환 및 음성 모방 도구의 도움을 받아 제작되었습니다.

Story link: https://insights.citeline.com/scrip/business/financing/neuroscience-drug-development-funding-poised-for-a-comeback-GEVK5NDEFRBSBKNEP67XY7QW6A/

 Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

뇌질환 신약 개발 펀딩 부활 조짐 (Korean-language podcast) Mar.19, 2026

What does it take to move from concept to commercial vaccine manufacturing at speed without compromising quality or compliance? In this conversation, leaders from Alfasigma’s CDMO arm, Morpho, share a detailed look at how they approached a complex vaccine technology transfer, from facility upgrades to regulatory approval. The discussion offers a grounded perspective on execution, coordination, and capability building in today’s evolving CDMO landscape.
 This podcast explores: 
•	The role of facility design, sterile manufacturing, and cold chain expansion
•	Why flexibility in equipment and formats matters for biological products
•	Approaches to contamination control and aseptic processing
•	Coordinating engineering, quality, and regulatory teams under tight timelines
•	What this project reveals about broader CDMO trends, from personalization to speed and sustainability

How a CDMO Created a Custom Vaccine Development Project

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, and Editor-in-Chief Nielsen Hobbs discuss the next steps after a federal judge ruled the reconstitution of the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), as well as recent changes to the childhood vaccine schedule, likely violated the law (:32). They also consider the responses to the decision from some controversial committee members (9:06) and prior ACIP priorities that now are delayed (14:50).

More On These Topics From The Pink Sheet

Federal Court Halts US CDC Vaccine Panel Appointments, Immunization Schedule Changes: https://insights.citeline.com/pink-sheet/vaccines/breaking-judge-stops-us-cdc-childhood-immunization-changes-acip-appointments-RBZR2RZY2BEU3IOXQT2MDBKKFM/

Fantasy Agenda: The ACIP Meeting That Could Have Been: https://insights.citeline.com/pink-sheet/vaccines/fantasy-agenda-the-acip-meeting-that-could-have-been-S4P2UO3G4FBOBAJGJUWRZ6IO6M/ 

Mail Not Enough? US FDA Considers New In-Home Opioid Disposal Requirements: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/mail-not-enough-us-fda-considers-new-in-home-opioid-disposal-requirements-W3VJOHOHYZCMZK4THBCE2GKKCY/ 

Drug Fix: ACIP Next Steps After Judge Stops Work, Potential Opioid Disposal Changes

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

Drug Fix: US FDA’s Prasad Leaves, Harry Potter, And Is CNPV Effective Because Of RTOR?

Citeline

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